I. Field of the Disclosure
A non-limiting embodiment relates to a method of promoting hair growth or preventing hair loss, comprising administering intradermally or subcutaneously Basic fibroblast growth factor (bFGF) or a mixture of bFGF with platelet rich plasma (PRP) and/or blood plasma.
II. Description of the Related Art
Hair loss can cause someone to look notably older than his or her actual age and can otherwise make him or her look less attractive. The cause of hair loss includes a part of the natural aging process, compromised hair growth cycle, genetic predisposition, unwanted side effects from medication and/or medical treatment, environmental causes such as allergies, infections, stress, a lack of proper diet and sleep, and/or other systematic disorders.
According to research results available in the web (e.g., www.statisticbrain.com/hair-loss-statistics), by age 35, it is estimated that 40% of males in the United States will have some noticeable hair loss. This condition gets worse as men get older. By age 60, it is estimated that 65% of adult males in the United States will suffer from noticeable hair loss. FIG. 1 shows that male-pattern baldness occurs in varying forms with a significant portion of the male population.
Women also suffer from hair loss. Female hair loss, unlike in men, typically involves noticeable thinning all over the head and the hairline. The American Academy of Dermatology reports that 40% of women have noticeable hair loss by the age 40. Despite this widespread problem, hair loss may not be seen as normal or acceptable for women due in part to social norms that may pressure women to look their best. Even a slight thinning of hair, if noticeable, may be undesirable to a woman's self-image and how others may judge her.
Therefore, many attempts to prevent and treat hair loss including medications, invasive surgical procedures, and injections have been made in the market. Medications such as MINOXIDIL® (Rogains), FINASTERIDE® (Propecia) and DUTASTERIDE® (Avodart) are an approved treatment for hair loss. However, these medications have shortcomings because, to be effective, the patient is required to take the medication daily. Further, the medication will work in the long term only if the patient continues to take the medication. Any discontinuance is likely to result in the loss of any hair gained. Moreover, some of these medications are not approved for use by women because of safety concerns.
Invasive hair loss treatment available includes surgical procedures such as follicle unit transplantation, scalp reduction or scalp flaps, and injection methods. These surgical procedures have a risk of possible skin necrosis or keloid scar tissue formation at donor region. These surgical procedures also often produce unsatisfactory results such as unnatural looking hair growth due to direction of hair growth and limitations on the number of hair follicles that can be safely transferred (less than 4000 hair follicles can be transferred every procedure with the maximum of 3 procedures in a patient's entire life). Such surgical treatment is also inconvenient for patients because it often requires 3-4 hours of operation, post-operative care, and disruption of normal daily living immediately after the surgery for approximately 2 weeks (even without complications).
Currently, there are also many different types of injection methods, such as methotherapy, plate rich plasma (PRP)-alone injection, PRP+ACELL® Injection, and others. A wealth of literature has already considered the use of PRP in sports medicine, orthopedic surgery, dental surgery, and a number of other medical and surgical specialties to enhance tissue repair and healing after surgical procedures or injury. Every platelet is a biochemical storehouse of regulatory, signaling and growth-factor molecules that participate in recovery and healing of tissue as well as emergency response to injury. Growth-factor molecules associated with platelets include: Platelet-derived growth factor (PDGF), Transforming growth-factor-beta (TGF-b), Vascular endothelial growth factor (VEGF), Epidermal growth factor (EGF), Fibroblast growth factor-2 (FGF-2), and Insulin-like growth factor (IGF) (International Society of Hair Restoration Surgery, Platelet-Rich Plasma in Hair Transplantation, Oct. 1, 2009).
Based on this literature, PRP injections and PRP+ACELL® Injection have been used for treating hair loss. However, the results of these injection methods vary widely. Often the results are conflicting and questionable. The existing injection method treatment, while restoring hair to some individuals, lacks the consistency to make it work for significant other populations suffering from hair loss.
Having perceived such lack of effective treatment for hair loss, the inventor looked at leading theories on hair loss, including (a) Dihydrotestosterone Theory, (b) Gravity Theory, and (c) Blood Supply Theory.
Dihydrotestosterone Theory is currently the leading theory hypothesizing that dihydrotestosterone (DHT) binds to hair follicles and shrinks hair follicles, making it impossible for healthy hair to survive. However, this theory does not explain why high levels of DHT do not affect hair loss to some individuals. Most men with high levels of DHT still have growing hair in the back of their heads and sides. In addition, these men also have healthy growing hair in other parts of their body such as armpit, legs, chest, and pubic area.
One theory trying to answer such paradoxical result of the Dihydrotestosterone Theory is the Gravity Theory of Hair Loss (“Gravity Theory”). This theory hypothesizes that the effects of gravity may be a contributing factor to hair loss. One special-topic paper in Plastic and Reconstruction Surgery reports that androgenic effect makes the thinning of the scalp. This thinning causes the scalp to have less ability to hold hair's weight firmly. This in turn causes hair to be unintentionally pulled out easier and earlier than the normal end of anagen (hair growing period) phase. Gravity gradually thins the skin on a person's scalp and this thinning of the skin causes the affected area to lose the ability to hold and grow hair. Emin Tuncay Ustuner reports that the thinned skin cannot afford the weight of hair for long and therefore hair can be pulled out easily (Cause of Androgenic Alopecia, Plastic & Reconstructive Surgery Global Open 2013; 1 DOI: 10.1097/GOX.0000000000000005).
There are three phases in a person's hair cycle: Anagen, Catagen, and Talogen. Anagen is the hair growing phase in the cycle, which in a healthy person typically lasts 4 to 6 years. Catagen is the phase in the cycle marking the end of the hair growth, which in a healthy person typically lasts 2 to 3 weeks. Finally, Talogen is the dormant (resting) phase marked by no growth of hair, which in a healthy person typically lasts 3 months.
According to the Gravity Theory, the thinning of the skin in the balding area of the head causes substantial shortening of Anagen phase (growth phase). The thinning of the skin also lengthens the Talogen phase.
Another theory, called Blood Supply Theory, argues that the cause of baldness is that a lack of blood supply to the follicles substantially shortens anagen phase (hair growth period) and prolongs talogen phase (resting—no hair growth phase). This theory is backed up by a product called MINOXIDIL® which was originally marketed as medication to treat high blood pressure based for its vasodilatation property on hypertension. It was discovered that one of MINOXIDIL®'s side effects was hair growth in bald and thinning areas. Because MINOXIDIL® enhances blood supply with its vasodilatation function, it is currently being used to treat hair loss. While the patient is administered MINOXIDIL®, blood supply to the follicles is increased and hair growth is temporarily stimulated.
Regardless of the theories explaining the causes of thinking hair or hair loss, there is not a treatment which provides satisfactory results of hair regain or hair growth promotion.
The present disclosure is directed to stimulating hair growth. An exemplary embodiment of stimulating hair growth shows that it thickens the skin in the target area by triggering fibrogenesis and tissue regeneration as well as increases the blood supply in the target area by making new blood vessels in the area.